Development and validation of a serological potency test for the release of Leptospira vaccines--requirements in the European Union.
作者信息
Balks Elisabeth, Gyra Heike, Kobe Babett, Cussler Klaus, Werner Esther
机构信息
Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Veterinary Department, Section Bacterial Vaccines and Immune Sera, Paul-Ehrlich-Institut-Strasse 51-59, 63225 Langen, Germany.
出版信息
Biologicals. 2013 Sep;41(5):325-9. doi: 10.1016/j.biologicals.2013.06.011. Epub 2013 Aug 1.
Both European Pharmacopoeia Monograph 01/2008:0447 "Canine Leptospirosis vaccine (inactivated)" and the more recent Monograph 01/2008:1939 "Bovine Leptospirosis vaccine (inactivated)" explicitly allow for a sero-response test to assess batch potency. Test setup and requirements for in vivo and in vitro validation are described. Furthermore, the two main strategies to assess batch potency and their specific demands are addressed.
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